mb-FIX Cranial Stabilization Systems— 510(k) K250423
Substantially EquivalentMedical Bees GmbH
FDA 510(k) clearance K250423 for mb-FIX Cranial Stabilization Systems, Substantially Equivalent on 2025-11-06. Applicant: Medical Bees GmbH. Device class: 2.
Clearance details
- Applicant
- Medical Bees GmbH
- Product code
- Code HBL
- Device class
- Class 2
- Regulation
- 21 CFR 882.4460
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Emmingen-Liptingen, DE
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Adverse events under product code HBL
product code HBL- Death
- 3
- Injury
- 753
- Malfunction
- 1,421
- Total
- 2,177
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.